BA-BE study for WOCKHARDTâ??S WOSULINÂ® N AND HUMULIN N

A Pilot Study To Compare Bioavailability Between Recombinant Human Isophane Insulin Injections Wockhardtâ??s WosulinÂ® N And Humulinï?? N, In Healthy Male Subjects - W-WOS(N)-103 (Protocol Number)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026261

Enrollment

Registered

2020-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: WosulinÂ® N,: cartridges 3.0 ml

0.4 IU/kg body weight of study drug will be administered subcutaneously. Control Intervention1: Humulin N,: Vials 10.0 ml

0.4 IU/kg body weight of study drug will be administered subcutaneously.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects weight within the normal range according to normal values for the Body Mass Index (18.50 to 27.00 kg/m2, both inclusive) with minimum of 50 kg weight. 2. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. 3. Subjects having clinically acceptable 12-lead electrocardiogram (ECG). 4. Subjects having clinically acceptable chest X-Ray (PA view). 5. Non-smoker, defined as no nicotine consumption for last six months

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to Insulin or related class of drugs. 2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3. Subjects with hemoglobin levels 4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration 5. History or presence of significant alcoholism or drug abuse in the past one year. 6. HbA1c values (at screening) >=5.7%

Design outcomes

Primary

Measure	Time frame
PK:AUC0-24and Cmax PD:AUCGIR,0-24,and GIRmaxTimepoint: PK:AUC0-24and Cmax PD:AUCGIR,0-24,and GIRmax	—

Secondary

Measure	Time frame
AEs, hematology, biochemistry, urinalysis, physical examination, vital signs, ECGs, blood glucose level and local tolerability.Timepoint: 2 â?? 10 weeks from screening to follow up visit;PK endpoints: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h, AUC12-24h, AUC0-ï?¥, tmax, tÂ½ and terminal serum insulin elimination half-life PD endpoints: AUCGIR,0-4h, AUCGIR,0-6h, AUCGIR,0-12h, AUCGIR,6- 12h, AUCGIR,6-24h, AUCGIR,12-24h and tGIRmax Timepoint: 24 hrs	—

Measure

Time frame

AEs, hematology, biochemistry, urinalysis, physical examination, vital signs, ECGs, blood glucose level and local tolerability.Timepoint: 2 â?? 10 weeks from screening to follow up visit;PK endpoints: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h, AUC12-24h, AUC0-ï?¥, tmax, tÂ½ and terminal serum insulin elimination half-life PD endpoints: AUCGIR,0-4h, AUCGIR,0-6h, AUCGIR,0-12h, AUCGIR,6- 12h, AUCGIR,6-24h, AUCGIR,12-24h and tGIRmax Timepoint: 24 hrs

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Countries

India

Contacts

Public ContactDr Mushtaque Mastim

Wockhardt Limited

mmastim@wockhardt.com

Outcome results